Impurity assay strategy lives at the intersection of science and regulatory expectation.

Quantera BioAnalytics builds methods and strategies grounded in the frameworks regulators actually apply.

ICH Q6B

ICH Q6B governs specifications and test procedures for biotechnological and biological products, and identifies host cell proteins as process-related impurities requiring a sensitive, broadly reactive immunoassay method, with acceptance criteria justified using preclinical, clinical, process consistency, and stability data.

We design HCP assays and specification strategies to meet this standard directly.

ICH Q2

ICH Q2 defines the validation characteristics expected of an analytical method: accuracy, precision, specificity, linearity, range, detection and quantitation limits, and robustness. Every validation package we produce is structured against this framework.

USP and Ph. Eur.

We apply relevant USP general chapters and European Pharmacopoeia monographs governing impurity testing in biologics, ensuring methods and documentation are consistent with both US and EU pharmacopeial expectations.

FDA and EMA Expectations

We advise on FDA and EMA expectations around HCP antibody coverage, the choice between platform and process-specific assays, and comparability protocols required when a process, site, or assay changes during development or after approval.